CFS is characterized by an abrupt onset of flu-like symptoms and persistent fatigue. Other symptoms include musculoskeletal pain; abnormal sleep patterns; neuropsychiatric symptoms such as headaches, blurred vision, dizziness, forgetfulness, excessive irritability, inability to concentrate, and depression; low grade fever; pharyngitis; swollen lymph nodes and weight loss. Many patients also have immunologic abnormalities. See Anthony L. Komaroff, Clinical Presentation and Evaluation of Fatigue and Chronic Fatigue Syndrome in Chronic Fatigue Syndrome 61, 70-71 (Stephen E. Straus, ed., 1994).
In 1990 researchers estimated that there were somewhere between three and five million cases of CFS in the United States (Cowley, G. Hager, M., Nadine, J., Chronic Fatigue Syndrome, A Debilitating Disease Afflicts Millions-And the Cause is Still a Mystery, Newsweek, Nov. 12, 1990). An accurate assessment is complicated by the lack of a reliable test for CFS and the fact that many CFS patients are misdiagnosed as having cancer, multiple sclerosis, depression, or Lyme disease.
A human retrovirus family, including human immunodeficiency virus type 1 (HIV-1) and human immunodeficiency virus type 2 (HIV-2), is accepted by most scientists as the primary infectious agent causing AIDS. However, some patients with AIDS-like symptoms are not HIV positive. This has led scientists to investigate alternate causes of AIDS-like symptoms in patients who are HIV negative.
Dr. Shyh-Ching Lo of the Armed Forces Institute of Pathology has found a novel pathogenic mycoplasma, Mycoplasma fermentans in patients with AIDS-like symptoms, some of whom were HIV negative. Although not all AIDS patients test positive for active mycoplasma, it is possible that the mycoplasma is in an inactive, hidden form in such patients. Some scientists have postulated that HIV is a largely benign viral infection which does not develop into AIDS unless there is also an infection with mycoplasma.
Dr. Lo isolated M. fermentans (then identified as Virus-Like Infectious Agents, or VLIA) from an AIDS patient and infected four silver leaf monkeys. All four died within 9 months and experienced symptoms similar to AIDS patients. Dr. Lo's research team could find no other pathogens that could have caused the monkeys' deaths. Shyh-Ching Lo, et al., Fatal Infection of Silvered Leaf Monkeys with a Virus-Like Infectious Agent (VLIA) Derived From a Patient with AIDS, Am. J. Trop. Med. Hyg., 40(4), pp. 399-409 (1989). Dr. Lo summarized medical research linking M. fermentans and AIDS in Mycoplasmas and AIDS in Mycoplasmas: Molecular Biology and Pathogenesis 525-545 (Jack Maniloff, et al., eds., American Society for Microbiology, 1992).
AIDS and CFS are both syndromes characterized by sustained and progressive illness. Patients can be chronically ill for years with symptoms that wax and wane, or, alternately, exhibit a steady progression toward disability or death. Many of the symptoms associated with CFS are also found in patients with AIDS. These include enlarged lymph nodes, musculoskeletal pain, headache, fatigue, weight loss, depression, and inability to concentrate. See Victor G. Daniels, AIDS 83-92 (MTP Press Limited 1987). In addition, AIDS and CFS patients are subject to opportunistic infections by many of the same viruses, such as Cytomegalovirus, Epstein-Barr virus, Herpes Simplex Virus, Non-A, Non-B Hepatitis (Hepatitis C), and Human T Cell Lymphotropic Viruses, types I and II (HTLV). Hepatitis C and HTLV are extremely rare in the North American heterosexual population. (Cowley, G., et al., supra, A Debilitating Disease Afflicts Millions-And the Cause is Still a Mystery, Newsweek, Nov. 12, 1990; Cowley, G., AIDS or Chronic Fatigue?, Newsweek, Sep. 7, 1992) This suggests that AIDS and CFS may share at least some similar immunosuppressive effects.
Historically, compositions derived from herbs have been used to treat a wide variety of diseases. Potent pharmacological substances have been identified in various herbal preparations, reflective of a pharmacological basis for their effects. The present invention is directed to a pharmaceutically effective composition derived from herbs which is useful in alleviating the symptoms associated with CFS and AIDS and to a method for so using these compositions.